Regulatory Analyst
Position Description
Founded in 1976, CGI is among the largest independent IT and business consulting services firms in the world. With 94,000 consultants and professionals across the globe, CGI delivers an end-to-end portfolio of capabilities, from strategic IT and business consulting to systems integration, managed IT and business process services and intellectual property solutions. CGI works with clients through a local relationship model complemented by a global delivery network that helps clients digitally transform their organizations and accelerate results. CGI Fiscal 2024 reported revenue is CA$14.68 billion and CGI shares are listed on the TSX (GIB.A) and the NYSE (GIB). Learn more at cgi.com.
Job Title: Regulatory Analyst
Position: Software Engineer
Experience: 2+ Years
Main Location: Hyd/Ban/Che/Pun
Position ID: J1026-1434
Employment Type: Full Time
Position Description:
We are looking for a Regulatory Analyst to work closely with onshore and offshore Lead Business Analysts to understand functional requirements and support regulatory data cleansing, migration, and integration activities. The ideal candidate should have experience in Regulatory Affairs, Regulatory Publishing, CMC Authoring, eCTD, NeeS and paper publishing, regulatory labelling, and quality control processes. The role involves preparing mapping documents, collaborating with technical teams, and ensuring the accuracy and correctness of implementation.
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Your future duties and responsibilities
• Work with onshore and offshore Lead Business Analysts to understand functional requirements.
• Prepare mapping documents for data cleansing, migration, and integration.
• Collaborate with technical teams to ensure correct implementation of functional requirements.
• Support regulatory data migration and integration activities.
• Perform regulatory publishing activities, including eCTD, NeeS, and paper publishing.
• Support CMC Authoring and regulatory labelling activities.
• Handle QC fixes and support quality control activities.
• Work with relevant QC and publisher tools to support regulatory processes.
Required qualifications to be successful in this role
Must-Have Skills:
• Experience in Regulatory Affairs.
• Experience in Regulatory Publishing.
• Experience in CMC Authoring.
• Knowledge of eCTD, NeeS, and paper publishing.
• Experience in QC fixes and migration.
• Experience in Regulatory Labelling.
• Familiarity with QC tools such as SmartDesk, ISI Toolbox, and ACUTA RIM.
• Familiarity with publisher tools such as Veeva Vault, Lorenz, and Insight Suite.
• Ability to understand functional requirements and prepare mapping documents for data cleansing, migration, and integration.
• Ability to collaborate with onshore/offshore business analysts and technical teams.
Good-to-Have Skills:
• Additional relevant skills to be confirmed.
CGI is an equal opportunity employer. In addition, CGI is committed to providing accommodation for people with disabilities in accordance with applicable legislation. Please let us know if you require reasonable accommodation due to a disability during any aspect of the recruitment process, and we will work with you to address your needs.
Life at CGI:
It is rooted in ownership, teamwork, respect and belonging. Here, you’ll reach your full potential because…
You are invited to be an owner from day 1 as we work together to bring our Dream to life. That’s why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company’s strategy and direction.
Your work creates value. You’ll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise.
You’ll shape your career by joining a company built to grow and last. You’ll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons.
Come join our team, one of the largest IT and business consulting services firms in the world.
Together, as owners, let’s turn meaningful insights into action. Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you’ll reach your full potential because…
You are invited to be an owner from day 1 as we work together to bring our Dream to life. That’s why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company’s strategy and direction.
Your work creates value. You’ll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise.
You’ll shape your career by joining a company built to grow and last. You’ll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons.
That same commitment to fairness extends to how we use technology. To support our recruitment team, AI tools may be used to help assess applications though they never replace human judgement. All hiring decisions remain entirely in the hands of our recruitment professionals.
Come join our team—one of the largest IT and business consulting services firms in the world.